Nirmatrelvir And RitonavirPaxlovid
Treatment of mild to moderate COVID-19 in patients at high risk of severe disease requiring hospitalisation, including persons aged ≥70 years, immunocompromised persons aged ≥18 years, Aboriginal and Torres Strait Islander persons aged ≥30 years with risk factors, and persons aged 50–69 years with risk factors.
Decisions on record
- Meeting Nov 2023 Noted Mild to moderate SARS-CoV-2 infection (high-risk patients)
- Meeting Sep 2022 Recommended Treatment of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection no PSD
Access path
- TGA registered · Paxlovid
TGA label narrower than the PBS population
- Nov 2023Recommended · restricted
vs placebo (no antiviral medication) and molnupiravir
- PBS listing · Authority Required
From the public summary
The PBAC provided advice regarding nirmatrelvir and ritonavir (Paxlovid), for the treatment of patients with mild to moderate Coronavirus disease (COVID-19) who are at high risk of severe disease requiring hospitalisation.PSD · Nov 2023
The PBAC noted the input received from individuals and organisations which supported the ongoing listing of nirmatrelvir and ritonavir and described a range of benefits of treatment including potential to reduce symptoms and prevent severe COVID.PSD · Nov 2023
The submission presented five cost-utility analyses that compared costs and quality- adjusted survival over a lifetime in patients treated with: • nirmatrelvir and ritonavir • molnupiravir • placebo (representing no antiviral treatment) 35PSD · Nov 2023
• Persons aged ≥ 18 years who are moderately to severely immunocompromised or had previously required hospitalisation for COVID-19;PSD · Nov 2023
The submission described nirmatrelvir and ritonavir as superior in terms of effectiveness compared to placebo (representing no antiviral treatment). The ESC considered that a claim of superiority was supported for high risk patients, including vaccinated patients, however, the data were less convincing for patients at lower risk of developing severe COVID 19.PSD · Nov 2023
The submission described nirmatrelvir and ritonavir as similar in terms of safety compared to placebo (representing no antiviral treatment). This claim was poorly supported. The ESC considered that, although nirmatrelvir and ritonavir was generally well tolerated, the incidence of dysgeusia was statistically significantly higher in patients treated with nirmatrelvir and ritonavir than in placebo-treated patients in both the EPIC-HR and EPIC-SR trials.PSD · Nov 2023
The PBAC noted and welcomed the input from individuals (3), and organisations (2) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with nirmatrelvir and ritonavir including potential to reduce symptoms and prevent severe COVID. The input also described concerns about long COVID, and a desire for expanded access to the medicine beyond the groups that are eligible currently.PSD · Nov 2023
The Lung Foundation Australia (LFA) described the health, financial and social cost of COVID-19 in Australia. The input supported the ongoing PBS listing of nirmatrelvir and ritonavir for people at increased risk of severe disease, noting that benefits may include reduced risk of severe infection, hospitalisation, and death in people with mild to moderate COVID-19. Additional benefits may include reduced duration of the person feeling unwell.PSD · Nov 2023
Cost-effectiveness
No ICER values stated in the public document; the submission requested maintenance of listing based on cost-effectiveness analysis but specific ICER figures are not provided in the PSD.
Decision context
PopulationAdults with mild to moderate COVID-19 at high risk of severe disease: (i) persons aged ≥70 years, (ii) persons aged ≥18 years who are moderately to severely immunocompromised or had previously required hospitalisation for COVID-19, (iii) Aboriginal and Torres Strait Islander persons aged ≥30 years with ≥1 risk factor, and (iv) persons aged 50–69 years with ≥1 risk factor.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2023 | Recommended · restricted | placebo (no antiviral medication) and molnupiravir | — | RCT · COVID-related hospitalisation or death |
Clinical evidence
Consumer voice
Consumer input from 3 individuals and 2 organisations (Lung Foundation Australia and Rare Cancers Australia) supported PBS listing of nirmatrelvir and ritonavir, describing benefits including reduced symptoms, prevention of severe COVID, and reduced healthcare burden. Input also raised concerns about long COVID and costs for those ineligible for PBS access, with calls for expanded access beyond cu
The comments described a range of benefits of treatment with nirmatrelvir and ritonavir including potential to reduce symptoms and prevent severe COVID. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to specific age/risk groups (≥70, immunocompromised ≥18, Aboriginal/Torres Strait Islander ≥30 with risk factors, 50–69 with risk factors) versus TGA's broader 'increased risk' criterion.